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Savient Pharmaceuticals Meets With FDA for End-of-Phase 2 Review of Puricase(R); Phase 3 Trial Expected to Commence in First Quarter of 2006

Posted on: Thursday, 28 July 2005, 06:00 CDT

Savient Pharmaceuticals, Inc. (NASDAQ:SVNT), an emerging specialty pharmaceuticals company focused on developing, manufacturing and marketing novel therapeutic products for unmet medical needs, announced today that it completed its previously scheduled end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for Puricase(R), Savient's drug candidate for the treatment of refractory gout. The Company will continue to work with the FDA to finalize the details of the Phase 3 clinical program designed to evaluate the drug's effectiveness in the control of uric acid and multiple clinical outcomes. Additionally, the Company has elected to submit a Special Protocol Assessment (SPA) to the FDA for the Phase 3 program.

The SPA is a formal process that establishes a binding, written agreement between the FDA and the sponsoring company regarding clinical trial design, endpoints, study conduct, data analysis, and other fundamentals of the study protocol.

"We are pleased with the results of this meeting and look forward to working diligently with the FDA to complete the SPA process and initiate our Phase 3 clinical program for Puricase. Our decision to submit an SPA will reduce the regulatory risk for Puricase and provide a clear path to marketing approval," commented Christopher Clement, President and Chief Executive Officer of Savient. "Thus far, Puricase has demonstrated encouraging results and we remain confident in its novel therapeutic potential to treat severe refractory gout."

The Company expects to initiate the Phase 3 program for Puricase during the first quarter of 2006. In May of 2005, Savient reported positive top-line Phase 2 clinical trial results for Puricase. Results demonstrated efficacy in reducing uric acid levels and indicated appropriate dosing for Phase 3. Additionally, during the Phase 2 study there were encouraging anecdotal reports of clinical benefits appearing within the 3-month study period, such as eradication of gout tophi and improvements in joint function and the patients' sense of well being. These outcomes will be studied formally in Phase 3, which could provide, for the first time, the first basis for a disease-modifying clinical benefit in patients with severe gout.

About Puricase

Puricase is a polyethylene glycol ("PEG") conjugate of recombinant porcine uricase (urate oxidase) for the treatment of patients with severe gout for whom conventional therapy is contraindicated or has been ineffective. The Company estimates approximately 35,000 to 50,000 patients in the United States. In February 2001, Savient received FDA Orphan Drug designation for Puricase.

About Savient Pharmaceuticals, Inc.

Savient Pharmaceuticals, Inc., an emerging specialty pharmaceuticals company, is engaged in developing, manufacturing, and marketing pharmaceutical products that address unmet medical needs in both niche and broader markets. Products marketed by Savient in the United States are Oxandrin(R) (oxandrolone, USP) and Delatestryl(R) (testosterone enanthate). The Company's subsidiary, Rosemont Pharmaceuticals Limited, develops, manufactures, and markets through its own sales force oral liquid formulations of prescription products for the UK pharmaceutical market. Savient's product Mircette(R), an oral contraceptive, is marketed by its licensee, Organon, Inc. Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc. Savient's news releases and other information are available on the Company's website at www.savientpharma.com.

Safe Harbor Statement

This news release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. All statements, other than statements of historical facts, included in this report regarding the Company's strategy, expected future financial position, discovery and development of products, strategic alliances, competitive position, plans and objectives of management are forward-looking statements. Words such as "anticipate,""believe,""estimate,""expect,""intend,""plan,""will" and other similar expressions help identify forward-looking statements, although not all forward-looking statements contain these identifying words. In particular, the statements regarding the estimated net proceeds from the sale of the global biologics manufacturing business, the continued implementation of the Company's strategic plan, the development of the Company's pipeline, the commencement of Phase 3 clinical trials for Puricase and growth at Rosemont are forward-looking statements. These forward-looking statements involve substantial risks and uncertainties and are based on current expectations, assumptions, estimates and projections about the Company's business and the biopharmaceutical and specialty pharmaceutical industries in which the Company operates. Such risks and uncertainties include, but are not limited to, delay or failure in developing Prosaptide, Puricase and other product candidates; difficulties of expanding the Company's product portfolio through in-licensing; introduction of generic competition for Oxandrin; fluctuations in buying patterns of wholesalers; potential future returns of Oxandrin or other products; our continuing to incur substantial net losses for the foreseeable future; difficulties in obtaining financing; potential development of alternative technologies or more effective products by competitors; reliance on third-parties to manufacture, market and distribute many of the Company's products; economic, political and other risks associated with foreign operations; risks of maintaining protection for the Company's intellectual property; risks of an adverse determination in on-going or future intellectual property litigation; and risks associated with stringent government regulation of the biopharmaceutical and specialty pharmaceutical industries. The Company may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on the Company's forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that the Company makes. The Company's forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that the Company may make. The Company does not assume any obligation to update any forward-looking statements.

Source: Business Wire

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